Product review on the IMD serogroup B vaccine Bexsero®

References

• World Health Organisation. Defeating meningitis by 2030. 2020.
   Google Scholar
• Rosenstein NE, Fischer M, Tappero JW. Meningococcal vaccines. Infect Dis Clin North Am. 2001;15:155–14. doi:10.1016/S0891-5520(05)70273-7.
   PubMed Web of Science ®Google Scholar
• Cohn AC, MacNeil JR, Clark TA, Ortega-Sanchez IR, Briere EZ, Meissner HC, Baker CJ, Messonnier NE. Prevention and control of meningococcal disease: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Recomm Rep. 2013;62:1–28.
   PubMed Web of Science ®Google Scholar
• Whittaker R, Dias JG, Ramliden M, Kodmon C, Economopoulou A, Beer N, Pastore Celentano L. The epidemiology of invasive meningococcal disease in EU/EEA countries, 2004-2014. Vaccine. 2017;35:2034–41. doi:10.1016/j.vaccine.2017.03.007.
   PubMed Web of Science ®Google Scholar
• Deghmane AE, Taha S, Taha MK. Global epidemiology and changing clinical presentations of invasive meningococcal disease: a narrative review. Infect Dis (Lond). 2021;1–7. doi:10.1080/23744235.2021.1971289.
   PubMed Web of Science ®Google Scholar
• Dwilow R, Fanella S. Invasive meningococcal disease in the 21st century-an update for the clinician. Curr Neurol Neurosci Rep. 2015;15:2. doi:10.1007/s11910-015-0524-6.
   PubMed Web of Science ®Google Scholar
• Halperin SA, Bettinger JA, Greenwood B, Harrison LH, Jelfs J, Ladhani SN, McIntyre P, Ramsay ME, Safadi MA. The changing and dynamic epidemiology of meningococcal disease. Vaccine. 2012;30(Suppl 2):B26–36. doi:10.1016/j.vaccine.2011.12.032.
   PubMed Web of Science ®Google Scholar
• Esposito S, Principi N. Vaccine profile of 4CMenB: a four-component Neisseria meningitidis serogroup B vaccine. Expert Rev Vaccines. 2014;13:193–202. doi:10.1586/14760584.2014.874949.
   PubMed Web of Science ®Google Scholar
• Rosenstein NE, Perkins BA, Stephens DS, Popovic T, Hughes JM. Meningococcal disease. N Engl J Med. 2001;344:1378–88. doi:10.1056/NEJM200105033441807.
   PubMed Web of Science ®Google Scholar
• Caugant DA, Maiden MC. Meningococcal carriage and disease–population biology and evolution. Vaccine. 2009;27(Suppl 2):B64–70. doi:10.1016/j.vaccine.2009.04.061.
   PubMed Web of Science ®Google Scholar
• Trotter CL, Maiden MC. Meningococcal vaccines and herd immunity: lessons learned from serogroup C conjugate vaccination programs. Expert Rev Vaccines. 2009;8:851–61. doi:10.1586/erv.09.48.
   PubMed Web of Science ®Google Scholar
• Deghmane AE, Taha MK. Invasive bacterial infections in subjects with genetic and acquired susceptibility and impacts on recommendations for vaccination: a narrative review. Microorganisms. 2021;9:467. doi:10.3390/microorganisms9030467.
   PubMed Web of Science ®Google Scholar
• Harrison OB, Claus H, Jiang Y, Bennett JS, Bratcher HB, Jolley KA, Corton C, Care R, Poolman JT, Zollinger WD, et al. Description and nomenclature of Neisseria meningitidis capsule locus. Emerg Infect Dis. 2013;19:566–73. doi:10.3201/eid1904.111799.
   PubMed Web of Science ®Google Scholar
• Cohn AC, MacNeil JR, Harrison LH, Hatcher C, Theodore J, Schmidt M, Pondo T, Arnold KE, Baumbach J, Bennett N, et al. Changes in Neisseria meningitidis disease epidemiology in the United States, 1998-2007: implications for prevention of meningococcal disease. Clin Infect Dis. 2010;50:184–91. doi:10.1086/649209.
   PubMed Web of Science ®Google Scholar
• Parikh SR, Campbell H, Bettinger JA, Harrison LH, Marshall HS, Martinon-Torres F, Safadi MA, Shao Z, Zhu B, von Gottberg A, et al. The everchanging epidemiology of meningococcal disease worldwide and the potential for prevention through vaccination. J Infect. 2020;81:483–98. doi:10.1016/j.jinf.2020.05.079.
   PubMed Web of Science ®Google Scholar
• Harrison LH. Epidemiological profile of meningococcal disease in the United States. Clin Infect Dis. 2010;50(Suppl 2):S37–44. doi:10.1086/648963.
   PubMed Web of Science ®Google Scholar
• Finne J, Bitter-Suermann D, Goridis C, Finne U. An IgG monoclonal antibody to group B meningococci cross-reacts with developmentally regulated polysialic acid units of glycoproteins in neural and extraneural tissues. J Immunol. 1987;138:4402–07.
   PubMed Web of Science ®Google Scholar
• Finne J, Leinonen M, Makela PH. Antigenic similarities between brain components and bacteria causing meningitis. Implications for vaccine development and pathogenesis. Lancet. 1983;2:355–57. doi:10.1016/S0140-6736(83)90340-9.
   PubMed Web of Science ®Google Scholar
• Wyle FA, Artenstein MS, Brandt BL, Tramont EC, Kasper DL, Altieri PL, Berman SL, Lowenthal JP. Immunologic response of man to group B meningococcal polysaccharide vaccines. J Infect Dis. 1972;126:514–21. doi:10.1093/infdis/126.5.514.
   PubMed Web of Science ®Google Scholar
• Jennings HJ, Lugowski C. Immunochemistry of groups A, B, and C meningococcal polysaccharide-tetanus toxoid conjugates. J Immunol. 1981;127:1011–18.
   PubMed Web of Science ®Google Scholar
• Artenstein MS, Gold R, Zimmerly JG, Wyle FA, Schneider H, Harkins C. Prevention of meningococcal disease by group C polysaccharide vaccine. N Engl J Med. 1970;282:417–20. doi:10.1056/NEJM197002192820803.
   PubMed Web of Science ®Google Scholar
• Zollinger WD, Boslego J, Froholm LO, Ray JS, Moran EE, Brandt BL. Human bactericidal antibody response to meningococcal outer membrane protein vaccines. Antonie Van Leeuwenhoek. 1987;53:403–11. doi:10.1007/BF00415494.
   PubMed Web of Science ®Google Scholar
• Zollinger WD, Mandrell RE, Altieri P, Berman S, Lowenthal J, Artenstein MS. Safety and immunogenicity of a Neisseria meningitidis type 2 protein vaccine in animals and humans. J Infect Dis. 1978;137:728–39. doi:10.1093/infdis/137.6.728.
   PubMed Web of Science ®Google Scholar
• Helting TB, Guthohrlein G, Blackkolb F, Ronneberger H. Serotype determinant protein of Neisseria Meningitidis. Large scale preparation by direct detergent treatment of the bacterial cells. Acta Pathol Microbiol Scand C. 1981;89:69–78.
   PubMedGoogle Scholar
• Frasch CE, Robbins JD. Protection against group B meningococcal disease. III. Immunogenicity of serotype 2 vaccines and specificity of protection in a Guinea pig model. J Exp Med. 1978;147:629–44. doi:10.1084/jem.147.3.629.
   PubMed Web of Science ®Google Scholar
• Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. II. Development of natural immunity. J Exp Med. 1969;129:1327–48. doi:10.1084/jem.129.6.1327.
   PubMed Web of Science ®Google Scholar
• Goldschneider I, Gotschlich EC, Artenstein MS. Human immunity to the meningococcus. I. The role of humoral antibodies. J Exp Med. 1969;129:1307–26. doi:10.1084/jem.129.6.1307.
   PubMed Web of Science ®Google Scholar
• Holst J, Oster P, Arnold R, Tatley MV, Naess LM, Aaberge IS, Galloway Y, McNicholas A, O’Hallahan J, Rosenqvist E, et al. Vaccines against meningococcal serogroup B disease containing outer membrane vesicles (OMV): lessons from past programs and implications for the future. Hum Vaccin Immunother. 2013;9:1241–53. doi:10.4161/hv.24129.
   PubMed Web of Science ®Google Scholar
• Morley SL, Cole MJ, Ison CA, Camaraza MA, Sotolongo F, Anwar N, Cuevas I, Carbonero M, Campa HC, Sierra G, et al. Immunogenicity of a serogroup B meningococcal vaccine against multiple Neisseria meningitidis strains in infants. Pediatr Infect Dis J. 2001;20:1054–61. doi:10.1097/00006454-200111000-00010.
   PubMed Web of Science ®Google Scholar
• Granoff DM. Review of meningococcal group B vaccines. Clin Infect Dis. 2010;50(Suppl 2):S54–65. doi:10.1086/648966.
   PubMed Web of Science ®Google Scholar
• Bjune G, Hoiby EA, Gronnesby JK, Arnesen O, Fredriksen JH, Halstensen A, Holten E, Lindbak AK, Nokleby H, Rosenqvist E, et al. Effect of outer membrane vesicle vaccine against group B meningococcal disease in Norway. Lancet. 1991;338:1093–96. doi:10.1016/0140-6736(91)91961-S.
   PubMed Web of Science ®Google Scholar
• Sierra GV, Campa HC, Varcacel NM, Garcia IL, Izquierdo PL, Sotolongo PF, Casanueva GV, Rico CO, Rodriguez CR, Terry MH. Vaccine against group B Neisseria meningitidis: protection trial and mass vaccination results in Cuba. NIPH Ann. 1991;14:195–207. discussion 8-10.
   PubMedGoogle Scholar
• de Moraes JC, Perkins BA, Camargo MC, Hidalgo NT, Barbosa HA, Sacchi CT, Landgraf IM, Gattas VL, Vasconcelos Hde G, Sacchi CT, et al. Protective efficacy of a serogroup B meningococcal vaccine in Sao Paulo, Brazil. Lancet. 1992;340:1074–78. doi:10.1016/0140-6736(92)93086-3.
   PubMed Web of Science ®Google Scholar
• Thornton V, Lennon D, Rasanathan K, O’Hallahan J, Oster P, Stewart J, Tilman S, Aaberge I, Feiring B, Nokleby H, et al. Safety and immunogenicity of New Zealand strain meningococcal serogroup B OMV vaccine in healthy adults: beginning of epidemic control. Vaccine. 2006;24:1395–400. doi:10.1016/j.vaccine.2005.09.043.
   PubMed Web of Science ®Google Scholar
• Boslego J, Garcia J, Cruz C, Zollinger W, Brandt B, Ruiz S, Martinez M, Arthur J, Underwood P, Silva W, et al. Efficacy, safety, and immunogenicity of a meningococcal group B (15: P1.3)outer membrane protein vaccine in Iquique, Chile. Chilean National Committee for Meningococcal Disease. Vaccine. 1995;13:821–29. doi:10.1016/0264-410X(94)00037-N.
   PubMed Web of Science ®Google Scholar
• Holst J, Martin D, Arnold R, Huergo CC, Oster P, O’Hallahan J, Rosenqvist E. Properties and clinical performance of vaccines containing outer membrane vesicles from Neisseria meningitidis. Vaccine. 2009;27(Suppl 2):B3–12. doi:10.1016/j.vaccine.2009.04.071.
   PubMed Web of Science ®Google Scholar
• Arnold R, Galloway Y, McNicholas A, O’Hallahan J. Effectiveness of a vaccination programme for an epidemic of meningococcal B in New Zealand. Vaccine. 2011;29:7100–06. doi:10.1016/j.vaccine.2011.06.120.
   PubMed Web of Science ®Google Scholar
• Sacchi CT, Whitney AM, Popovic T, Beall DS, Reeves MW, Plikaytis BD, Rosenstein NE, Perkins BA, Tondella ML, Mayer LW. Diversity and prevalence of PorA types in Neisseria meningitidis serogroup B in the United States, 1992-1998. J Infect Dis. 2000;182:1169–76. doi:10.1086/315833.
   PubMed Web of Science ®Google Scholar
• van der Voort ER, van Dijken H, Kuipers B, van der Biezen J, van der Ley P, Meylis J, Claassen I, Poolman J. Human B- and T-cell responses after immunization with a hexavalent PorA meningococcal outer membrane vesicle vaccine. Infect Immun. 1997;65:5184–90. doi:10.1128/iai.65.12.5184-5190.1997.
   PubMed Web of Science ®Google Scholar
• Fisseha M, Chen P, Brandt B, Kijek T, Moran E, Zollinger W. Characterization of native outer membrane vesicles from lpxL mutant strains of Neisseria meningitidis for use in parenteral vaccination. Infect Immun. 2005;73:4070–80. doi:10.1128/IAI.73.7.4070-4080.2005.
   PubMed Web of Science ®Google Scholar
• Fleischmann RD, Adams MD, White O, Clayton RA, Kirkness EF, Kerlavage AR, Bult CJ, Tomb JF, Dougherty BA, Merrick JM, et al. Whole-genome random sequencing and assembly of Haemophilus influenzae Rd. Science. 1995;269:496–512. doi:10.1126/science.7542800.
   PubMed Web of Science ®Google Scholar
• Rappuoli R. Reverse vaccinology. Curr Opin Microbiol. 2000;3:445–50. doi:10.1016/S1369-5274(00)00119-3.
   PubMed Web of Science ®Google Scholar
• Rappuoli R. Reverse vaccinology, a genome-based approach to vaccine development. Vaccine. 2001;19:2688–91. doi:10.1016/S0264-410X(00)00554-5.
   PubMed Web of Science ®Google Scholar
• Rappuoli R. Conjugates and reverse vaccinology to eliminate bacterial meningitis. Vaccine. 2001;19:2319–22. doi:10.1016/S0264-410X(00)00552-1.
   PubMed Web of Science ®Google Scholar
• Plotkin SA. Vaccines: the fourth century. Clin vaccine immunol. 2009;16:1709–19. doi:10.1128/CVI.00290-09.
   PubMed Web of Science ®Google Scholar
• Tettelin H, Saunders NJ, Heidelberg J, Jeffries AC, Nelson KE, Eisen JA, Ketchum KA, Hood DW, Peden JF, Dodson RJ, et al. Complete genome sequence of Neisseria meningitidis serogroup B strain MC58. Science. 2000;287:1809–15. doi:10.1126/science.287.5459.1809.
   PubMed Web of Science ®Google Scholar
• Pizza M, Scarlato V, Masignani V, Giuliani MM, Arico B, Comanducci M, Jennings GT, Baldi L, Bartolini E, Capecchi B, et al. Identification of vaccine candidates against serogroup B meningococcus by whole-genome sequencing. Science. 2000;287:1816–20. doi:10.1126/science.287.5459.1816.
   PubMed Web of Science ®Google Scholar
• Bentley SD, Vernikos GS, Snyder LA, Churcher C, Arrowsmith C, Chillingworth T, Cronin A, Davis PH, Holroyd NE, Jagels K, et al. Meningococcal genetic variation mechanisms viewed through comparative analysis of serogroup C strain FAM18. PLoS Genet. 2007;3:e23. doi:10.1371/journal.pgen.0030023.
   PubMed Web of Science ®Google Scholar
• Wang X, Cohn A, Comanducci M, Andrew L, Zhao X, MacNeil JR, Schmink S, Muzzi A, Bambini S, Rappuoli R, et al. Prevalence and genetic diversity of candidate vaccine antigens among invasive Neisseria meningitidis isolates in the United States. Vaccine. 2011;29:4739–44. doi:10.1016/j.vaccine.2011.04.092.
   PubMed Web of Science ®Google Scholar
• Muzzi A, Mora M, Pizza M, Rappuoli R, Donati C. Conservation of meningococcal antigens in the genus Neisseria. MBio. 2013;4:e00163–13. doi:10.1128/mBio.00163-13.
   PubMed Web of Science ®Google Scholar
• Serruto D, Spadafina T, Ciucchi L, Lewis LA, Ram S, Tontini M, Santini L, Biolchi A, Seib KL, Giuliani MM, et al. Neisseria meningitidis GNA2132, a heparin-binding protein that induces protective immunity in humans. Proc Natl Acad Sci U S A. 2010;107:3770–75. doi:10.1073/pnas.0915162107.
   PubMed Web of Science ®Google Scholar
• Madico G, Welsch JA, Lewis LA, McNaughton A, Perlman DH, Costello CE, Ngampasutadol J, Vogel U, Granoff DM, Ram S. The meningococcal vaccine candidate GNA1870 binds the complement regulatory protein factor H and enhances serum resistance. J Immunol. 2006;177:501–10. doi:10.4049/jimmunol.177.1.501.
   PubMed Web of Science ®Google Scholar
• Schneider MC, Exley RM, Chan H, Feavers I, Kang YH, Sim RB, Tang CM. Functional significance of factor H binding to Neisseria meningitidis. J Immunol. 2006;176:7566–75. doi:10.4049/jimmunol.176.12.7566.
   PubMed Web of Science ®Google Scholar
• Serruto D, Bottomley MJ, Ram S, Giuliani MM, Rappuoli R. The new multicomponent vaccine against meningococcal serogroup B, 4CMenB: immunological, functional and structural characterization of the antigens. Vaccine. 2012;30(Suppl 2):B87–97. doi:10.1016/j.vaccine.2012.01.033.
   PubMed Web of Science ®Google Scholar
• Masignani V, Comanducci M, Giuliani MM, Bambini S, Adu-Bobie J, Arico B, Brunelli B, Pieri A, Santini L, Savino S, et al. Vaccination against Neisseria meningitidis using three variants of the lipoprotein GNA1870. J Exp Med. 2003;197:789–99. doi:10.1084/jem.20021911.
   PubMed Web of Science ®Google Scholar
• Seib KL, Brunelli B, Brogioni B, Palumbo E, Bambini S, Muzzi A, DiMarcello F, Marchi S, van der Ende A, Arico B, et al. Characterization of diverse subvariants of the meningococcal factor H (fH) binding protein for their ability to bind fH, to mediate serum resistance, and to induce bactericidal antibodies. Infect Immun. 2011;79:970–81. doi:10.1128/IAI.00891-10.
   PubMed Web of Science ®Google Scholar
• Schneider MC, Prosser BE, Caesar JJ, Kugelberg E, Li S, Zhang Q, Quoraishi S, Lovett JE, Deane JE, Sim RB, et al. Neisseria meningitidis recruits factor H using protein mimicry of host carbohydrates. Nature. 2009;458:890–93. doi:10.1038/nature07769.
   PubMed Web of Science ®Google Scholar
• Johnson S, Tan L, van der Veen S, Caesar J, Goicoechea De Jorge E, Harding RJ, Bai X, Exley RM, Ward PN, Ruivo N, et al. Design and evaluation of meningococcal vaccines through structure-based modification of host and pathogen molecules. PLoS Pathog. 2012;8:e1002981. doi:10.1371/journal.ppat.1002981.
   PubMed Web of Science ®Google Scholar
• Capecchi B, Adu-Bobie J, Di Marcello F, Ciucchi L, Masignani V, Taddei A, Rappuoli R, Pizza M, Arico B. Neisseria meningitidis NadA is a new invasion which promotes bacterial adhesion to and penetration into human epithelial cells. Mol Microbiol. 2005;55:687–98. doi:10.1111/j.1365-2958.2004.04423.x.
   PubMed Web of Science ®Google Scholar
• Franzoso S, Mazzon C, Sztukowska M, Cecchini P, Kasic T, Capecchi B, Tavano R, Papini E. Human monocytes/macrophages are a target of Neisseria meningitidis Adhesin A (NadA). J Leukoc Biol. 2008;83:1100–10. doi:10.1189/jlb.1207810.
   PubMed Web of Science ®Google Scholar
• Nagele V, Heesemann J, Schielke S, Jimenez-Soto LF, Kurzai O, Ackermann N. Neisseria meningitidis adhesin NadA targets beta1 integrins: functional similarity to Yersinia invasin. J Biol Chem. 2011;286:20536–46. doi:10.1074/jbc.M110.188326.
   PubMed Web of Science ®Google Scholar
• Montanari P, Bozza G, Capecchi B, Caproni E, Barrile R, Norais N, Capitani M, Sallese M, Cecchini P, Ciucchi L, et al. Human heat shock protein (Hsp) 90 interferes with Neisseria meningitidis adhesin A (NadA)-mediated adhesion and invasion. Cell Microbiol. 2012;14:368–85. doi:10.1111/j.1462-5822.2011.01722.x.
   PubMed Web of Science ®Google Scholar
• Vogel U, Taha MK, Vazquez JA, Findlow J, Claus H, Stefanelli P, Caugant DA, Kriz P, Abad R, Bambini S, et al. Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Europe: a qualitative and quantitative assessment. Lancet Infect Dis. 2013;13:416–25. doi:10.1016/S1473-3099(13)70006-9.
   PubMed Web of Science ®Google Scholar
• Lucidarme J, Comanducci M, Findlow J, Gray SJ, Kaczmarski EB, Guiver M, Vallely PJ, Oster P, Pizza M, Bambini S, et al. Characterization of fHbp, nhba (gna2132), nadA, porA, and sequence type in group B meningococcal case isolates collected in England and Wales during January 2008 and potential coverage of an investigational group B meningococcal vaccine. Clin Vaccine Immunol. 2010;17:919–29. doi:10.1128/CVI.00027-10.
   PubMed Web of Science ®Google Scholar
• Donnelly J, Medini D, Boccadifuoco G, Biolchi A, Ward J, Frasch C, Moxon ER, Stella M, Comanducci M, Bambini S, et al. Qualitative and quantitative assessment of meningococcal antigens to evaluate the potential strain coverage of protein-based vaccines. Proc Natl Acad Sci U S A. 2010;107:19490–95. doi:10.1073/pnas.1013758107.
   PubMed Web of Science ®Google Scholar
• Metruccio MM, Pigozzi E, Roncarati D, Berlanda Scorza F, Norais N, Hill SA, Scarlato V, Delany I. A novel phase variation mechanism in the meningococcus driven by a ligand-responsive repressor and differential spacing of distal promoter elements. PLoS Pathog. 2009;5:e1000710. doi:10.1371/journal.ppat.1000710.
   PubMed Web of Science ®Google Scholar
• Comanducci M, Bambini S, Caugant DA, Mora M, Brunelli B, Capecchi B, Ciucchi L, Rappuoli R, Pizza M. NadA diversity and carriage in Neisseria meningitidis. Infect Immun. 2004;72:4217–23. doi:10.1128/IAI.72.7.4217-4223.2004.
   PubMed Web of Science ®Google Scholar
• Bambini S, De Chiara M, Muzzi A, Mora M, Lucidarme J, Brehony C, Borrow R, Masignani V, Comanducci M, Maiden MC, et al. Neisseria adhesin A variation and revised nomenclature scheme. Clin vaccine immunol. 2014;21:966–71. doi:10.1128/CVI.00825-13.
   PubMed Web of Science ®Google Scholar
• Comanducci M, Bambini S, Brunelli B, Adu-Bobie J, Arico B, Capecchi B, Giuliani MM, Masignani V, Santini L, Savino S, et al. NadA, a novel vaccine candidate of Neisseria meningitidis. J Exp Med. 2002;195:1445–54. doi:10.1084/jem.20020407.
   PubMed Web of Science ®Google Scholar
• Giuliani MM, Adu-Bobie J, Comanducci M, Arico B, Savino S, Santini L, Brunelli B, Bambini S, Biolchi A, Capecchi B, et al. A universal vaccine for serogroup B meningococcus. Proc Natl Acad Sci U S A. 2006;103:10834–39. doi:10.1073/pnas.0603940103.
   PubMed Web of Science ®Google Scholar
• Findlow J, Lucidarme J, Taha MK, Burman C, Balmer P. Correlates of protection for meningococcal surface protein vaccines: lessons from the past. Expert Rev Vaccines. 2021;1–13. doi:10.1080/14760584.2021.1940144.
   Web of Science ®Google Scholar
• Frasch CE, Borrow R, Donnelly J. Bactericidal antibody is the immunologic surrogate of protection against meningococcal disease. Vaccine. 2009;27(Suppl 2):B112–6. doi:10.1016/j.vaccine.2009.04.065.
   PubMed Web of Science ®Google Scholar
• Holst J, Feiring B, Fuglesang JE, Hoiby EA, Nokleby H, Aaberge IS, Rosenqvist E. Serum bactericidal activity correlates with the vaccine efficacy of outer membrane vesicle vaccines against Neisseria meningitidis serogroup B disease. Vaccine. 2003;21:734–37. doi:10.1016/S0264-410X(02)00591-1.
   PubMed Web of Science ®Google Scholar
• Australian Government-Department of Health-Therapeutic Goods Administration. Australian public assessment report for multi-component meningococcal B vaccine. 2013 Oct 31.
   Google Scholar
• Committee for Medicinal Products for Human Use. European Medical Agency. Assessment Report: Bexsero M-cGBV.
   Google Scholar
• Kelly C, Arnold R, Galloway Y, O’Hallahan J. A prospective study of the effectiveness of the New Zealand meningococcal B vaccine. Am J Epidemiol. 2007;166:817–23. doi:10.1093/aje/kwm147.
   PubMed Web of Science ®Google Scholar
• Oster P, Lennon D, O’Hallahan J, Mulholland K, Reid S, Martin D. MeNZB: a safe and highly immunogenic tailor-made vaccine against the New Zealand Neisseria meningitidis serogroup B disease epidemic strain. Vaccine. 2005;23:2191–96. doi:10.1016/j.vaccine.2005.01.063.
   PubMed Web of Science ®Google Scholar
• Australian Government. Therapeutic Goods Administration. Bexsero meningococcal B vaccine. Final update - monitoring finds no new or unexpected safety issues. Australian Government. Therapeutic Goods Administration. 2016 Mar 22.
   Google Scholar
• Snape MD, Dawson T, Oster P, Evans A, John TM, Ohene-Kena B, Findlow J, Yu LM, Borrow R, Ypma E, et al. Immunogenicity of two investigational serogroup B meningococcal vaccines in the first year of life: a randomized comparative trial. Pediatr Infect Dis J. 2010;29:e71–9. doi:10.1097/INF.0b013e3181f59f6d.
   PubMed Web of Science ®Google Scholar
• Borrow R, Balmer P, Miller E. Meningococcal surrogates of protection–serum bactericidal antibody activity. Vaccine. 2005;23:2222–27. doi:10.1016/j.vaccine.2005.01.051.
   PubMed Web of Science ®Google Scholar
• Santolaya ME, O’Ryan ML, Valenzuela MT, Prado V, Vergara R, Munoz A, Toneatto D, Grana G, Wang H, Clemens R, et al. Immunogenicity and tolerability of a multicomponent meningococcal serogroup B (4CMenB) vaccine in healthy adolescents in Chile: a phase 2b/3 randomised, observer-blind, placebo-controlled study. Lancet. 2012;379:617–24. doi:10.1016/S0140-6736(11)61713-3.
   PubMed Web of Science ®Google Scholar
• Martinon-Torres F, Nolan T, Toneatto D, Banzhoff A. Persistence of the immune response after 4CMenB vaccination, and the response to an additional booster dose in infants, children, adolescents, and young adults. Hum Vaccin Immunother. 2019;15:2940–51. doi:10.1080/21645515.2019.1627159.
   PubMed Web of Science ®Google Scholar
• Gossger N, Snape MD, Yu LM, Finn A, Bona G, Esposito S, Principi N, Diez-Domingo J, Sokal E, Becker B, et al. Immunogenicity and tolerability of recombinant serogroup B meningococcal vaccine administered with or without routine infant vaccinations according to different immunization schedules: a randomized controlled trial. Jama. 2012;307:573–82. doi:10.1001/jama.2012.85.
   PubMed Web of Science ®Google Scholar
• Iro MA, Snape MD, Voysey M, Jawad S, Finn A, Heath PT, Bona G, Esposito S, Diez-Domingo J, Prymula R, et al. Persistence of bactericidal antibodies following booster vaccination with 4CMenB at 12, 18 or 24 months and immunogenicity of a fifth dose administered at 4 years of age-a phase 3 extension to a randomised controlled trial. Vaccine. 2017;35:395–402. doi:10.1016/j.vaccine.2016.11.009.
   PubMed Web of Science ®Google Scholar
• Snape MD, Philip J, John TM, Robinson H, Kelly S, Gossger N, Yu LM, Kittel C, Toneatto D, Dull PM, et al. Bactericidal antibody persistence 2 years after immunization with 2 investigational serogroup B meningococcal vaccines at 6, 8 and 12 months and immunogenicity of preschool booster doses: a follow-on study to a randomized clinical trial. Pediatr Infect Dis J. 2013;32:1116–21. doi:10.1097/INF.0b013e31829cfff2.
   PubMed Web of Science ®Google Scholar
• McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Houlden J, Voysey M, Toneatto D, Kitte C, Dull PM, et al. Persistence of bactericidal antibodies to 5 years of age after immunization with serogroup B meningococcal vaccines at 6, 8, 12 and 40 months of age. Pediatr Infect Dis J. 2014;33:760–66. doi:10.1097/INF.0000000000000327.
   PubMed Web of Science ®Google Scholar
• Ladhani SN, Andrews N, Parikh SR, Campbell H, White J, Edelstein M, Bai X, Lucidarme J, Borrow R, Ramsay ME. Vaccination of Infants with Meningococcal Group B Vaccine (4CMenB) in England. N Engl J Med. 2020;382:309–17. doi:10.1056/NEJMoa1901229.
   PubMed Web of Science ®Google Scholar
• Nolan T, Santolaya ME, de Looze F, Marshall H, Richmond P, Henein S, Rheault P, Heaton K, Perrett KP, Garfield H, et al. Antibody persistence and booster response in adolescents and young adults 4 and 7.5 years after immunization with 4CMenB vaccine. Vaccine. 2019;37:1209–18. doi:10.1016/j.vaccine.2018.12.059.
   PubMed Web of Science ®Google Scholar
• Christensen H, May M, Bowen L, Hickman M, Trotter CL. Meningococcal carriage by age: a systematic review and meta-analysis. Lancet Infect Dis. 2010;10:853–61. doi:10.1016/S1473-3099(10)70251-6.
   PubMed Web of Science ®Google Scholar
• Kimura A, Toneatto D, Kleinschmidt A, Wang H, Dull P. Immunogenicity and safety of a multicomponent meningococcal serogroup B vaccine and a quadrivalent meningococcal CRM197 conjugate vaccine against serogroups A, C, W-135, and Y in adults who are at increased risk for occupational exposure to meningococcal isolates. Clin Vaccine Immunol. 2011;18:483–86. doi:10.1128/CVI.00304-10.
   PubMed Web of Science ®Google Scholar
• Vesikari T, Esposito S, Prymula R, Ypma E, Kohl I, Toneatto D, Dull P, Kimura A. Immunogenicity and safety of an investigational multicomponent, recombinant, meningococcal serogroup B vaccine (4CMenB) administered concomitantly with routine infant and child vaccinations: results of two randomised trials. Lancet. 2013;381:825–35. doi:10.1016/S0140-6736(12)61961-8.
   PubMed Web of Science ®Google Scholar
• Toneatto D, Ismaili S, Ypma E, Vienken K, Oster P, Dull P. The first use of an investigational multicomponent meningococcal serogroup B vaccine (4CMenB) in humans. Hum Vaccin. 2011;7:646–53. doi:10.4161/hv.7.6.15482.
   PubMed Web of Science ®Google Scholar
• Snape MD, Saroey P, John TM, Robinson H, Kelly S, Gossger N, Yu LM, Wang H, Toneatto D, Dull PM, et al. Persistence of bactericidal antibodies following early infant vaccination with a serogroup B meningococcal vaccine and immunogenicity of a preschool booster dose. CMAJ. 2013;185:E715–24. doi:10.1503/cmaj.130257.
   PubMed Web of Science ®Google Scholar
• McQuaid F, Snape MD, John TM, Kelly S, Robinson H, Yu LM, Toneatto D, D’Agostino D, Dull PM, Pollard AJ. Persistence of specific bactericidal antibodies at 5 years of age after vaccination against serogroup B meningococcus in infancy and at 40 months. Can Med Assoc J = journal de l’association medicale canadienne. 2015;187:E215–E23. doi:10.1503/cmaj.141200.
   PubMed Web of Science ®Google Scholar
• Prymula R, Esposito S, Zuccotti GV, Xie F, Toneatto D, Kohl I, Dull PM. A phase 2 randomized controlled trial of a multicomponent meningococcal serogroup B vaccine (I). Hum Vaccin Immunother. 2014;10:1993–2004. doi:10.4161/hv.28666.
   PubMed Web of Science ®Google Scholar
• Oster P, O’Hallahan J, Aaberge I, Tilman S, Ypma E, Martin D. Immunogenicity and safety of a strain-specific MenB OMV vaccine delivered to under 5-year olds in New Zealand. Vaccine. 2007;25:3075–79. doi:10.1016/j.vaccine.2007.01.023.
   PubMed Web of Science ®Google Scholar
• Trials C. Safety and immunogenicity in dose-ranging and formulation-finding meningococcal B (MenB) vaccine study in 2-month-old Infants.
   Google Scholar
• European Medicine Agency. Bexerso: EPAR-Public assessment report.
   Google Scholar
• Graves RC, Oehler K, Tingle LE. Febrile seizures: risks, evaluation, and prognosis. Am Fam Physician. 2012;85:149–53.
   PubMed Web of Science ®Google Scholar
• Bryan P, Seabroke S, Wong J, Donegan K, Webb E, Goldsmith C, Vipond C, Feavers I. Safety of multicomponent meningococcal group B vaccine (4CMenB) in routine infant immunisation in the UK: a prospective surveillance study. Lancet Child Adolesc Health. 2018;2:395–403. doi:10.1016/S2352-4642(18)30103-2.
   PubMedGoogle Scholar
• Trials C. A Phase 3b, single-center, open-label study to assess the immunogenicity and safety of Novartis meningococcal B recombinant vaccine when administered at a 0, 2-Month schedule in healthy at-risk adults aged 18 to 65 years inclusive.
   Google Scholar
• Stefanizzi P, Bianchi FP, Spinelli G, Amoruso F, Ancona D, Stella P, Tafuri S. Postmarketing surveillance of adverse events following meningococcal B vaccination: data from Apulia Region, 2014-19. Hum Vaccin Immunother. 2021;1–6. doi:10.1080/21645515.2021.1963171
   Web of Science ®Google Scholar
• Stowe J, Andrews NJ, Turner PJ, Miller E. The risk of Kawasaki disease after pneumococcal conjugate & meningococcal B vaccine in England: a self-controlled case-series analysis. Vaccine. 2020;38:4935–39. doi:10.1016/j.vaccine.2020.05.089.
   PubMed Web of Science ®Google Scholar
• Marshall HS, Koehler AP, Wang B, A’Houre M, Gold M, Quinn H, Crawford N, Pratt N, Sullivan TR, Macartney K. Safety of meningococcal B vaccine (4CMenB) in adolescents in Australia. Vaccine. 2020;38:5914–22. doi:10.1016/j.vaccine.2020.07.009.
   PubMed Web of Science ®Google Scholar
• Watson PS, Turner DP. Clinical experience with the meningococcal B vaccine, Bexsero((R)): prospects for reducing the burden of meningococcal serogroup B disease. Vaccine. 2016;34:875–80. doi:10.1016/j.vaccine.2015.11.057.
   PubMed Web of Science ®Google Scholar
• Mentzer D, Oberle D, Keller-Stanislawski B. Adverse events following immunisation with a meningococcal serogroup B vaccine: report from post-marketing surveillance, Germany, 2013 to 2016. Euro Surveill 2018; 23.
   Google Scholar
• van der Ley P, van Den Dobbelsteen G. Next-generation outer membrane vesicle vaccines against Neisseria meningitidis based on nontoxic LPS mutants. Hum Vaccin. 2011;7:886–90. doi:10.4161/hv.7.8.16086.
   PubMed Web of Science ®Google Scholar
• Frasch CE, van Alphen L, Holst J, Poolman JT, Rosenqvist E. Outer membrane protein vesicle vaccines for meningococcal disease. Methods Mol Med. 2001;66:81–107. doi:10.1385/1-59259-148-5:81.
   PubMedGoogle Scholar
• Martin NG, Snape MD. A multicomponent serogroup B meningococcal vaccine is licensed for use in Europe: what do we know, and what are we yet to learn? Expert Rev Vaccines. 2013;12:837–58. doi:10.1586/14760584.2013.814862.
   PubMed Web of Science ®Google Scholar
• Medini D, Stella M, Wassil J. MATS: global coverage estimates for 4CMenB, a novel multicomponent meningococcal B vaccine. Vaccine. 2015;33:2629–36. doi:10.1016/j.vaccine.2015.04.015.
   PubMed Web of Science ®Google Scholar
• Snape MD, Medini D, Halperin SA, DeTora L, Drori J, Moxon ER. The challenge of post-implementation surveillance for novel meningococcal vaccines. Vaccine. 2012;30(Suppl 2):B67–72. doi:10.1016/j.vaccine.2011.12.126.
   PubMed Web of Science ®Google Scholar
• Muzzi A, Brozzi A, Serino L, Bodini M, Abad R, Caugant D, Comanducci M, Lemos AP, Gorla MC, Krizova P, et al. Genetic Meningococcal Antigen Typing System (gMATS): a genotyping tool that predicts 4CMenB strain coverage worldwide. Vaccine. 2019;37:991–1000. doi:10.1016/j.vaccine.2018.12.061.
   PubMed Web of Science ®Google Scholar
• Parikh SR, Newbold L, Slater S, Stella M, Moschioni M, Lucidarme J, De Paola R, Giuliani M, Serino L, Gray SJ, et al. Meningococcal serogroup B strain coverage of the multicomponent 4CMenB vaccine with corresponding regional distribution and clinical characteristics in England, Wales, and Northern Ireland, 2007-08 and 2014-15: a qualitative and quantitative assessment. Lancet Infect Dis. 2017;17:754–62. doi:10.1016/S1473-3099(17)30170-6.
   PubMed Web of Science ®Google Scholar
• Rajam G, Stella M, Kim E, Paulos S, Boccadifuoco G, Serino L, Carlone G, Medini D. Meningococcal Antigen Typing System (MATS)-Based Neisseria meningitidis Serogroup B Coverage Prediction for the MenB-4C Vaccine in the United States. mSphere. 2017;2. doi:10.1128/mSphere.00261-17.
   PubMed Web of Science ®Google Scholar
• Simoes MJ, Bettencourt C, De Paola R, Giuliani M, Pizza M, Moschioni M, Machado J. Predicted strain coverage of a meningococcal multicomponent vaccine (4CMenB) in Portugal. PLoS One. 2017;12:e0176177. doi:10.1371/journal.pone.0176177.
   PubMed Web of Science ®Google Scholar
• Tzanakaki G, Hong E, Kesanopoulos K, Xirogianni A, Bambini S, Orlandi L, Comanducci M, Muzzi A, Taha MK. Diversity of Greek meningococcal serogroup B isolates and estimated coverage of the 4CMenB meningococcal vaccine. BMC Microbiol. 2014;14:111. doi:10.1186/1471-2180-14-111.
   PubMed Web of Science ®Google Scholar
• Frosi G, Biolchi A, Lo Sapio M, Rigat F, Gilchrist S, Lucidarme J, Findlow J, Borrow R, Pizza M, Giuliani MM, et al. Bactericidal antibody against a representative epidemiological meningococcal serogroup B panel confirms that MATS underestimates 4CMenB vaccine strain coverage. Vaccine. 2013;31:4968–74. doi:10.1016/j.vaccine.2013.08.006.
   PubMed Web of Science ®Google Scholar
• Abad R, Biolchi A, Moschioni M, Giuliani MM, Pizza M, Vazquez JA. A large portion of meningococcal antigen typing system-negative meningococcal strains from Spain is killed by sera from adolescents and infants immunized with 4CMenB. Clin Vaccine Immunol. 2015;22:357–60. doi:10.1128/CVI.00669-14.
   PubMed Web of Science ®Google Scholar
• Budroni S, Kleinschmidt A, Boucher P, Medini D. Pooled-sera hSBA titres predict individual seroprotection in infants and toddlers vaccinated with 4CMenB. Vaccine. 2016;34:2579–84. doi:10.1016/j.vaccine.2016.04.009.
   PubMed Web of Science ®Google Scholar
• Biolchi A, De Angelis G, Moschioni M, Tomei S, Brunelli B, Giuliani M, Bambini S, Borrow R, Claus H, Gorla MCO, et al. Multicomponent meningococcal serogroup B vaccination elicits cross-reactive immunity in infants against genetically diverse serogroup C, W and Y invasive disease isolates. Vaccine. 2020;38:7542–50. doi:10.1016/j.vaccine.2020.09.050.
   PubMed Web of Science ®Google Scholar
• Biolchi A, Tomei S, Brunelli B, Giuliani M, Bambini S, Borrow R, Claus H, Gorla MCO, Hong E, Lemos APS, et al. 4CMenB immunization induces serum bactericidal antibodies against non-serogroup B meningococcal strains in adolescents. Infect Dis Ther. 2021;10:307–16. doi:10.1007/s40121-020-00370-x.
   PubMed Web of Science ®Google Scholar
• Hong E, Giuliani MM, Deghmane AE, Comanducci M, Brunelli B, Dull P, Pizza M, Taha MK. Could the multicomponent meningococcal serogroup B vaccine (4CMenB) control Neisseria meningitidis capsular group X outbreaks in Africa? Vaccine. 2013;31:1113–16. doi:10.1016/j.vaccine.2012.12.022.
   PubMed Web of Science ®Google Scholar
• Ladhani SN, Giuliani MM, Biolchi A, Pizza M, Beebeejaun K, Lucidarme J, Findlow J, Ramsay ME, Borrow R. Effectiveness of meningococcal B vaccine against endemic hypervirulent Neisaseria meningitidis W Strain, England. Emerg Infect Dis. 2016;22:309–11. doi:10.3201/eid2202.150369.
   PubMed Web of Science ®Google Scholar
• Ladhani SN, Campbell H, Andrews N, Parikh SR, White J, Edelstein M, Clark SA, Lucidarme J, Borrow R, Ramsay ME. First real world evidence of meningococcal group B vaccine, 4CMenB, protection against meningococcal group W disease; prospective enhanced national surveillance, England. Clin Infect Dis . 2021;73:e1661-e8. Epub 2020/08/28.
   Web of Science ®Google Scholar
• Maiden MC, Stuart JM; Group UKMC. Carriage of serogroup C meningococci 1 year after meningococcal C conjugate polysaccharide vaccination. Lancet. 2002;359:1829–31. doi10.1016/S0140-6736(02)08679-8.
   PubMed Web of Science ®Google Scholar
• Kristiansen PA, Diomande F, Ba AK, Sanou I, Ouedraogo AS, Ouedraogo R, Sangare L, Kandolo D, Ake F, Saga IM, et al. Impact of the serogroup A meningococcal conjugate vaccine, MenAfriVac, on carriage and herd immunity. Clin Infect Dis. 2013;56:354–63. doi:10.1093/cid/cis892.
   PubMed Web of Science ®Google Scholar
• de Greeff SC, de Melker HE, Spanjaard L, Schouls LM, van Derende A. Protection from routine vaccination at the age of 14 months with meningococcal serogroup C conjugate vaccine in the Netherlands. Pediatr Infect Dis J. 2006;25:79–80. doi:10.1097/01.inf.0000195594.41449.c6.
   PubMed Web of Science ®Google Scholar
• Read RC, Baxter D, Chadwick DR, Faust SN, Finn A, Gordon SB, Heath PT, Lewis DJ, Pollard AJ, Turner DP, et al. Effect of a quadrivalent meningococcal ACWY glycoconjugate or a serogroup B meningococcal vaccine on meningococcal carriage: an observer-blind, phase 3 randomised clinical trial. Lancet. 2014;384:2123–31. doi:10.1016/S0140-6736(14)60842-4.
   PubMed Web of Science ®Google Scholar
• Marshall HS, McMillan M, Koehler AP, Lawrence A, Sullivan TR, MacLennan JM, Maiden MCJ, Ladhani SN, Ramsay ME, Trotter C, et al. Meningococcal B vaccine and meningococcal carriage in adolescents in Australia. N Engl J Med. 2020;382:318–27. doi:10.1056/NEJMoa1900236.
   PubMed Web of Science ®Google Scholar
• Kesanopoulos K, Bratcher HB, Hong E, Xirogianni A, Papandreou A, Taha MK, Maiden MCJ, Tzanakaki G. Characterization of meningococcal carriage isolates from Greece by whole genome sequencing: implications for 4CMenB vaccine implementation. PLoS One. 2018;13:e0209919. doi:10.1371/journal.pone.0209919.
   PubMed Web of Science ®Google Scholar
• Lemee L, Hong E, Etienne M, Deghmane AE, Delbos V, Terrade A, Berthelot G, Caron F, Taha MK. Genetic diversity and levels of expression of factor H binding protein among carriage isolates of Neisseria meningitidis. PLoS One. 2014;9:e107240. doi:10.1371/journal.pone.0107240.
   PubMed Web of Science ®Google Scholar
• Rodrigues FMP, Marlow R, Simoes MJ, Danon L, Ladhani S, Finn A. Association of use of a meningococcus group B vaccine with group B invasive meningococcal disease among children in Portugal. JAMA. 2020;324:2187–94. doi:10.1001/jama.2020.20449.
   PubMed Web of Science ®Google Scholar
• Azzari C, Moriondo M, Nieddu F, Guarnieri V, Lodi L, Canessa C, Indolfi G, Giovannini M, Napoletano G, Russo F, et al. Effectiveness and impact of the 4CMenB vaccine against group B meningococcal disease in two Italian regions using different vaccination schedules: a five-year retrospective observational study (2014-2018). Vaccines. 2020;8:469. doi:10.3390/vaccines8030469.
   Web of Science ®Google Scholar